# K133397: P-POD

- Pathway: 510(k) (Traditional)
- Applicant: P-Pod
- Decided: Apr 18, 2014 after 163 days
- Product code: MVA (Orthosis, Cranial)
- Device class: 2
- Regulation: 21 CFR 882.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN980001 (1998). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072566: Hanger Cranial Band, Hanger Prosthetics & Orthotics, Inc. (2008) Summary page 1.
- K021918: Clarren Helmet (Orthomerica), Orthomerica Products, Inc. (2002) Summary page 1.

## Most influential descendants
- K193383: SnugKap (2021), 0 descendants of its own

## Indications for use
The P-POD Plagiocephaly Orthosis Device is intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is intended to treat infants from four to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

Source page: https://510kreport.com/device/K133397
Methodology: https://510kreport.com/methodology